Home / 510(k) Clearances / K821018

510(k) K821018

ANTIHUMAN IGG GLOBULIN FITC LABELED by Microbiological Research Corp. — Product Code DEW

K821018 is an FDA 510(k) premarket notification submitted by Microbiological Research Corp. for the device "ANTIHUMAN IGG GLOBULIN FITC LABELED". The FDA issued a decision of Substantially Equivalent on April 29, 1982. The device falls under product code DEW (Igg, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Microbiological Research Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1982
Date Received
April 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Microbiological Research Corp.

  • K883011 — MRI NEO-TRYP TRYPSIN RIA (April 26, 1989)
  • K861123 — THE GOLDEN QUAD TEST (CMV) (February 2, 1987)
  • K861121 — THE GOLDEN QUAD TEST (EBV) (February 2, 1987)
  • K861120 — THE GOLDEN QUAD TEST (HSV) (February 2, 1987)
  • K861122 — THE GOLDEN QUAD TEST (TOXO) (February 2, 1987)
  • K860450 — THE CMV-IGM TEST (May 13, 1986)
  • K843138 — CMV TEST (January 29, 1985)
  • K821019 — PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU (April 26, 1982)
  • K803134 — TOXOPLASMA GONDII SEROLOGICAL REAGENTS (January 29, 1981)
  • K803175 — RUBELLA VIRUS SEROLOGICAL REAGENTS (January 29, 1981)

Other clearances for product code DEW

  • K050113 — TINA-QUANT IGG GEN.2 (February 8, 2005)
  • K040434 — ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 (March 10, 2004)
  • K010617 — SPIFE IFE CALIBRATOR AND CONTROL KIT (March 15, 2001)
  • K993928 — WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD (January 18, 2000)
  • K993281 — K-ASSAY IGG (November 9, 1999)
  • K983221 — IGG (November 4, 1998)
  • K965108 — SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT (March 6, 1997)
  • K963974 — IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN (March 6, 1997)
  • K963868 — IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) (February 10, 1997)
  • K962202 — QUANTEX IGG (September 26, 1996)

FDA data resources